For professional use only. 

In vitro diagnostic test for the qualitative detection of Respiratory Syncytial Virus antigens(viral fusion protein). 

Includes:

• Test Cassettes
• Extraction Buffer Tubes
• Sterile swabs
• Workstation
• IFU

Test Procedure 

1. Directions for use

Allow the test, specimen and extraction buffer to equilibrate to room temperature (15-30℃) prior to testing. 1. Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will be obtained if the assay is performed immediately after opening the foil pouch. 2. Tear off the aluminium foil on the extraction buffer tube. 3. Place the swab specimen in the extraction buffer tube. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the extraction buffer tube body to release the antigen in the swab. 4. Slightly lift the nasal swab then break the swab on the “break point” position. Leave the swab head in the sample collection vial and dispose of swab handle in accordance with your biohazard waste disposal protocol. 5. Fit the dropper tip on top of the extraction buffer tube. Place the test cassette on a clean and flat surface. Do not move the test cassette during the test. Hold the dropper vertically and transfer 3 drops of the sample solution (approx.80μL) to both sample wells and then start the timer. 7. Read the result at 10 minutes. Do not interpret the result after 20 minutes